Marshall Vein Ethanol Infusion in Addition to Pulsed Electric Field Ablation Versus Pulsed Electric Field Ablation Alone for Paroxysmal Atrial Fibrillation (MARVEL-PAF)

The Marvel-PAF trial is an investigator initiated, multi-center, open-label, randomized trial, which aims to compare the effectiveness of vein of Marshall in addition to pulmonary vein isolation using pulsed field ablation in the treatment of paroxysmal atrial fibrillation. The primary endpoint is any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Procedure: vein of Marshall ethanol infusion; Procedure: PVI using pulsed field ablation

• Study Type: Interventional
• Enrollment (Estimated): 340
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caihua Sang, MD; Phone Number: +86 010-81992280; Email: sch9613070@sina.com
• Study Contact Backup: Name: Yiwei Lai; Email: yiweil0624@foxmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital Affiliated to Capital Medical University
      • Contact: Caihua Sang; Phone Number: +86 010-81992280; Email: sch9613070@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age over 18 years;
2. With symptomatic* paroxysmal AF;
3. Undergoing first AF ablation;
4. At least one AF lasting over 30s documented by 12-lead ECG, Holter, or other rhythm monitoring device in the past 12 months;

5. Able to understand the purpose of the study, willing to receive randomization of the ablation strategy, and able to be followed up as required, voluntarily participate in the study and signed a written informed consent.

   • Symptoms include but not restricted to palpitations, dizziness, fatigue, or shortness of breath and chest discomfort

Exclusion Criteria:

1. Diagnosed with persistent atrial fibrillation or duration of atrial fibrillation >7 days;
2. Thrombosis in the heart cavity;
3. Contraindications to oral anticoagulants including the presence of a history of heparin-induced thrombocytopenia;
4. Transient/reversible atrial fibrillation due to electrolyte disorders, thyroid disease or other non-cardiac-related causes;
5. Acute coronary syndrome in the past 3 months or coronary intervention or coronary artery bypass treatment;
6. Stroke or transient ischemic attacks (TIA) in the past 3 months;
7. History of cardiac surgery or other surgical history involving left atrium, such as previous left atrial catheter ablation, atrial septal defect repair, etc.;
8. History of previous severe valvular disease (severe mitral stenosis or regurgitation), congenital heart disease, hypertrophic cardiomyopathy or dilated cardiomyopathy;
9. TEE examination in the past 12 months showed that the left atrium diameter of the parasternal long axis section was ≥55mm;
10. Other factors that are not suitable for surgery (such as history of organ transplant surgery or ongoing evaluation of organ transplant surgery, life expectancy less than 1 year, uncontrolled cancer, pregnancy, breastfeeding, or planning to get pregnant, etc.);
11. Other patients who were not suitable for enrollment in this study after the investigator's evaluation;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PFA-PVI + EIVOM group; PVI will be performed with PFA first, then EIVOM will be performed to achieve potential cardiac autonomous nerve modulation while reinforce LPV isolation.	Procedure: vein of Marshall ethanol infusion; After PFA, the coronary sinus venography will be acquired in search of VOM ostium. Then an over-the-wire balloon will be sent into the VOM and deflated with 4-6 atm. Selective VOM venography will be performed, followed by injection of 10ml 95% ethanol into the VOM.; Procedure: PVI using pulsed field ablation; Bilateral pulmonary vein antrum ablation using a pulsed field ablation
Active Comparator: PFA-PVI group; PVI will be performed with PFA only	Procedure: PVI using pulsed field ablation; Bilateral pulmonary vein antrum ablation using a pulsed field ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period	12 months after procedure excluding the 2-month blanking period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any atrial arrhythmias lasting ≥30s with or without AAD during 12 months after procedure excluding the 2-months blanking period		12 months after procedure excluding the 2-months blanking period
Any atrial flutter/atrial tachycardia lasting ≥30s during 12 months after procedure excluding the 2-months blanking period		12 months after procedure excluding the 2-months blanking period
Any atrial arrhythmias after multiple ablation with or without AADs		12 months after first procedure excluding the 2-months blanking period
AF burden	Total AF/AFL time devided by total monitoring time	12 months after procedure excluding the 2-months blanking period
procedural complications		30 days after the procedure
Change in quality of life	Assessed by AFEQT scale	at baseline and 12 months after procedure

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2025
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 22, 2025
• First Submitted That Met QC Criteria: July 29, 2025
• First Posted (Actual): July 31, 2025

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Anti-Infective Agents; Physiological Effects of Drugs; Central Nervous System Depressants; Anti-Infective Agents, Local; Ethanol
• Other Study ID Numbers: MARVEL-PAF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data will be shared only upon reasonable request to the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No